FARAPULSE Ablation for Atrial Fibrillation
(ADVANTAGE AF Trial)

Recruiting in Palo Alto (17 mi)

+57 other locations

Vivek Reddy, MD - Physician's Channel ...

Overseen byVivek Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a device that uses electrical pulses to treat patients with persistent atrial fibrillation who do not respond to drugs. The device works by creating small scars in the heart to block abnormal electrical signals and restore normal rhythm.

Research Team

Vivek Reddy, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for adults with symptomatic, drug-resistant persistent atrial fibrillation (AF) that's been continuous for more than 7 days but less than a year. Participants must have tried at least one antiarrhythmic drug without success and be able to attend all study-related tests. Exclusions include secondary AF due to reversible causes, severe heart conditions, certain pre-existing medical devices or implants, recent stroke or bleeding events, pregnancy, uncontrolled health issues like diabetes or sleep apnea, and those currently in other conflicting studies.

Inclusion Criteria

I have persistent AF that's resistant to at least one heart rhythm medication.

I am at least 18 years old or meet the age requirement by local law.

I am willing and able to give my consent for treatment.

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Exclusion Criteria

If you have a LUX-Dx device that was put in more than 6 months ago and is expected to last less than 1 year, you cannot participate.

I cannot have a device implanted under my skin for health reasons.

I have severe lung disease or need extra oxygen.

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Treatment Details

Interventions

FARAPULSE Ablation System (Pulsed Field Ablation System)

Trial OverviewThe ADVANTAGE AF Study is testing the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System as a treatment option for people with persistent AF who haven't responded well to drugs. It's an open-label study where all participants receive the same intervention using this new ablation system designed specifically for their condition.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Pulsed Field Ablation (Phase 2)Experimental Treatment1 Intervention

PHASE 2 only

Group II: Pulsed Field Ablation (Phase 1)Experimental Treatment1 Intervention

PHASE 1 only